Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients
NCT ID: NCT00974285
Last Updated: 2009-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2009-09-30
2010-12-31
Brief Summary
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Detailed Description
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* Immunity 1 (Fuzheng 1) is composed of herbs which have tonic and detoxific function. The long-term clinical application has proved the safety and effect. It can improve the symptoms and signs in AIDS patients with the effective rate of 70% and can significantly improve the quality of life. It can also improve and stabilize immune function and inhibit viral replication. The basis study have shown that Immunity 1 (Fuzheng 1) can inhibit viral replication from multi-target, multi-link, enhance immune function, increase the secretion of IL-2, IFN-γ, participate in immune regulation effect, enhance NK cell activity, promote CD3+CD4+T cell proliferation and increase macrophage phagocytes capacity.
* Through the clinical trials, we are going to evaluate the efficacy and safety of Immunity 1 (Fuzheng 1) on immune reconstitution of HIV patients in WHOⅠ、II period.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fuzheng 1
Immunity 1 (Fuzheng 1), 8.75g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Fuzheng 1
Immunity 1 (Fuzheng 1), 8.75g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Placebo
Placebo, 8.75g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Placebo
Placebo, 8.75g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Interventions
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Fuzheng 1
Immunity 1 (Fuzheng 1), 8.75g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Placebo
Placebo, 8.75g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Eligibility Criteria
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Inclusion Criteria
* CD 4 counts\> 350 cells / ul and \<550 cells / ul
* Age ≥ 18 years old and ≤ 70 years old
* Voluntary participated in this study, signed informed consent form, and could be followed-up
Exclusion Criteria
* Participated in clinical trials of other drugs within one month before the experiment
* Received antiretroviral therapy or are anti-HIV drugs such as nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs) and fusion-inhibiting agent (FIs), integrase inhibitors, inhibitors penetration within one month before the experiment
* Received immunomodulatory treatment within one month before the experiment Liver and kidney dysfunction (AST, ALT, T-BIL ≥2 times of upper limit of the reference value or creatinine ≥ 2 times of the upper limit of reference value)
* Patients with obvious active diseases in respiratory system, digestive system, circulatory system, blood system, neuroendocrine system, or genitourinary system diseases
* Persons suffering from autoimmune diseases
* Cancer patients which need chemotherapy
* Pregnant or lactating women, and did not use safe contraceptive measures for women of child-bearing age, as well as the male that can not take a reasonable method of contraception in trial period
* Hypersensitive people
* Patients with dysgnosia or language barriers, which can not fully understand the test or cooperate well
18 Years
70 Years
ALL
No
Sponsors
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Principal Investigators
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Jie WANG, MD
Role: STUDY_CHAIR
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Locations
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Jie, WANG
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jie LIU, MD
Role: primary
Other Identifiers
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09.07.16-3
Identifier Type: -
Identifier Source: org_study_id